FDA Device recall Z-1643-2016
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit
- FDA Device
- Class I
- terminated
- Published 2016-05-18
On 2016-05-18 the FDA classified a Class I recall of Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit by Biomerieux, citing product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1643-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-02-24 |
| Published | 2016-05-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | n/a |
Product
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Reason
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Identifiers
| code_info | Lots 742343610 exp. 5/11/16, 742347220 exp. 6/16/16, 742350010 exp. 7/14/16, 742352820 exp. 8/11/16, 742355710 exp. 9/9…Lots 742343610 exp. 5/11/16, 742347220 exp. 6/16/16, 742350010 exp. 7/14/16, 742352820 exp. 8/11/16, 742355710 exp. 9/9/16, 742362540 exp. 11/16/16, 742364020 exp. 12/1/16, 742368210 exp. 1/12/16, 742376540 exp. 4/5/17, 742383610 exp. 6/15/17, and 742389220 exp. 8/10/17. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1643-2016%22
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